Bionpharma receives US FDA approval for Etravirine tablets developed in collaboration with STEERLife

Marking a significant milestone in the global effort to expand access to advanced HIV therapies, Bengaluru headquartered STEERLife (the life sciences division of STEER World), and Bionpharma announced that Bionpharma has received Abbreviated New Drug Application (ANDA) approval from the United States Food and Drug Administration (USFDA) for its generic Etravirine tablets.

Developed using STEERLife’s proprietary FragMelt continuous processing platform, this approval represents a breakthrough in pharmaceutical manufacturing. The platform enables a sustainable, solvent-free manufacturing route while maintaining strict bioequivalence to the reference product, INTELENCE. The partnership underscores a shared commitment to delivering high-quality, cost-effective, and environmentally conscious medical solutions to patients.

This approval allows Bionpharma to commercialise the product in the United States, expanding patient access to a high-quality, more affordable treatment option for HIV/AIDS.

Etravirine is an important second-line antiretroviral therapy for the treatment of HIV/AIDS. Its development posed significant technical challenges due to its extreme sensitivity to heat and shear.  Through a focused partnership, Bionpharma’s regulatory expertise and STEERLife’s engineering depth, formulation capabilities, and continuous processing technologies combined to overcome these barriers, converting a complex molecule into a stable, reproducible, and regulatory-compliant product.

A key enabler of this success was STEERLife’s proprietary FragMelt platform, which integrates advanced engineering and pharmaceutical sciences to enable continuous, solvent-free processing of heat- and shear-sensitive APIs. This approach allowed efficient solubilization and stabilization of the API while ensuring it meets stringent USFDA quality standards – an outcome that is often difficult to achieve using conventional batch manufacturing methods.

“This ANDA approval is a testament to the power of aligning scientific insight with advanced engineering from day one,” said Mr Venkat Krishnan, CEO of Bionpharma. “Our collaboration with STEERLife has converted a technically challenging product into a scalable, high-quality product ready for the competitive U.S. market” he said.

Indu Bhushan, CEO and Director of STEERLife, added, “FragMelt and our continuous processing approach were engineered specifically to solve complex formulation challenges such as these. This approval not only validates our platform but also reinforces the immense value of collaborative development and technology transfer in the generic pharmaceutical space.”

Impact of continuous manufacturing

The success of this program highlights several key advantages of STEERLife’s continuous manufacturing approach:

• Precision engineering:  FragMelt enables processing of heat-sensitive materials while meeting stringent USFDA quality expectations.
• Scalability and speed: Continuous processing ensures highly reproducible formulations and a rapid transition from development to commercial readiness.
• Sustainability: The solvent-free process reduces environmental impact while simplifying manufacturing operations.

Future Outlook

With ANDA approval secured, Bionpharma will lead the commercialization and distribution of Etravirine tablets in the United States. Both organizations view this achievement as a solid foundation for future collaborations on complex generics that require advanced processing solutions to reach global markets.